Lead Process Engineer

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we re working at the pace of change on diagnostic tools that address the world s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

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Do you want to work in Technical Operations, Do you enjoy as Lead Process Engineer, will be located in Mahadeva Kodigehalli, Bangalore, Karnataka (on-site).

Do you enjoy Then read on!

The Process Engineer is responsible for developing a strategy and executing plan to deliver continuous process performance improvements related to Safety, Quality, Delivery, and Cost of a manufacturing process or line. The Process Engineer will work with continuous improvement initiatives and be responsible for overall equipment/process performance and executing equipment/process validations, including efficiency tracking and problem solving. The Process Engineer will also leverage process knowledge to identify opportunities/ solutions to improve throughput capacity by reducing the impact of constraints.

The role will require close interaction with the global teams. This person will be the technical partner to the engineering/manufacturing team in US/Sweden/India throughout the life cycle of the equipment/process.

In this role, you will be responsible for:

• Be the primary lead for defining and executing installation and validation processes for new or existing equipment and products in compliance with company standards, IVD regulations and GMP standards.
• Plan execute documentation as per QMS requirements, including preparation, writing, and filing of validation plans, SOPs, protocols and reports.
• Apply knowledge of relevant continuous improvement tools and approaches to increase production up-time, minimize unplanned maintenance, minimize work in process inventories (WIP) or plant inventories, and implement cost reduction initiatives across equipment and labor.
• Plan, compile and evaluate test data to determine appropriate limits and variables for process or material specifications.
• Provide and facilitate training to Manufacturing personnel and peers in equipment processes, validations, instructions, quality requirements, upgrades, or changes.

The required qualifications for the job include:

• Bachelors or master s in biotechnology or electrical or electronics or related engineering fields with minimum 3 years of experience in manufacturing, preferably in Medical Device/ IVD sectors.
• Strong background in equipment and product validation for medical device manufacturing. Understanding of mechanical design concepts and machinery: mixing processes, motors, pumps, vacuum, and hydraulics.
• Experience of working in a regulated work environment (ISO, GMP, Medical Device regulations)

It would be a plus if you also possess previous experience in:

• Working in a global environment. Strong communication, written and oral presentation skills (English).
• Strong analytical and problem-solving skills combined with a strong technical understanding. Experience with Lean manufacturing and Six Sigma.

Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com .

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